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Zoryve FDA Approval History

Last updated by Judith Stewart, BPharm on May 27, 2025.

FDA Approved: Yes (First approved July 29, 2022)
Brand name: Zoryve
Generic name: roflumilast
Dosage form: Cream and Foam
Company: Arcutis Biotherapeutics, Inc.
Treatment for: Plaque Psoriasis, Atopic Dermatitis, Seborrheic Dermatitis

Zoryve (roflumilast) is a topical phosphodiesterase 4 (PDE4) inhibitor indicated for the treatment of plaque psoriasis (0.3% cream, 0.3% foam), atopic dermatitis (0.15% cream) and seborrheic dermatitis (0.3% foam).

 

Development timeline for Zoryve

DateArticle
May 22, 2025Approval Arcutis’ Zoryve (roflumilast) Topical Foam 0.3% Approved by U.S. FDA for the Treatment of Plaque Psoriasis in Adults and Adolescents Ages 12 and Older
Jul  9, 2024Approval FDA Approves Arcutis’ Zoryve (roflumilast) Cream 0.15% for the Treatment of Atopic Dermatitis in Adults and Children Down to 6 Years of Age
Dec 15, 2023Approval FDA Approves Arcutis’ Zoryve (roflumilast) Topical Foam, 0.3% for the Treatment of Seborrheic Dermatitis in Individuals Aged 9 Years and Older
Oct  6, 2023Approval FDA Approves Arcutis’ Zoryve (roflumilast) Cream 0.3% for Treatment of Psoriasis in Children Ages 6 to 11
Jul 29, 2022Approval FDA Approves Zoryve (roflumilast) Cream for the Treatment of Plaque Psoriasis
Dec 22, 2021FDA Accepts Arcutis Biotherapeutics’ New Drug Application for Roflumilast Cream for Adults and Adolescents with Plaque Psoriasis
Oct  4, 2021Arcutis Submits Topical Roflumilast Cream New Drug Application to FDA for the Treatment of Adults and Adolescents with Plaque Psoriasis

Further information

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